Monday, 21 March 2011

Darvocet & Darvon Withdrawn Due to Cardiac Health Risks

Last month, the Food and Drug Administration finally acted to remove the painkilling drug propoxyphene, sold under the names Darvocet and Darvon, from the market altogether. The drug had been approved by the Food and Drug Administration back in 1957, and has been available for more than 50 years. It is an opiate pain reliever that has been used to treat mild to moderate pain. However, complaints linking Darvocet and Darvon to adverse cardiac effects have been around for years now.

Since 1978, the Food and Drug Administration has received at least two requests to remove the drug from the American market. However, the Food and Drug Administration has determined that the beneficial effects of the drug are far greater than any adverse health effects from its use. In 2009, the agency finally acted against the sales of the drug, when an FDA committee voted against the marketing of the propoxyphene. Later that year, the agency decided to allow continued marketing of the drug, but required manufacturers of Darvocet and Darvon to include a warning label on the packaging, informing consumers and doctors about the cardiac health risks with the use of these medications.

The agency also required that manufacturers conduct new studies into the safety of the use of propoxyphene on cardiac health. The study found that even when propoxyphene was taken at recommended levels, there was a serious effect on the heart. There was a change in electrical cardiac activity that posed a risk of serious, abnormal heart rhythms. This could even lead to sudden death. The study also found that a patient on Darvocet and Darvon may be at a special risk of sudden and serious side effects even if there were minor changes in the patient's health, like dehydration. Last year, the Food and Drug Administration announced a recall of Darvon from the market after studies conclusively proved that the drug increased the risk of cardiac arrhythmia or sudden cardiac death